SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on

FDA device recall Z-0100-2011 · posted 2010-10-20 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

For SoftLab version 4.01 ASCII, the qualifying test result does not reach the Call List because the order is locked by either another application, or two Hosparams (HISRR_RBS_sync and Auto_sync_RBS). This creates a lock on the RBS server. The problem was identified in the RBS "C" rule which sends qualifying results to the Call List for SoftLab. All affected clients received the upgrade for Soft

Action taken

SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System in June 2006. SCC recommended SoftLab version 4.01 ASCII users change program settings to prevent locking of the RBS server. A software upgrade with corrective patch will be delivered electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

131

Distribution

Nationwide Distribution: USA in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WV.

Date initiated

2006-08-04

Date posted

2010-10-20

Date terminated

2012-07-16

Location

Clearwater, FL